GOOGLE Policing Rogue Online Pharmacies...
How Google Is Trying to Protect Your Drug Supply
The Internet giant is working with the feds to address
the growing problem of illegal online pharmacies.
By Sophie Novack March 5, 2014
The upside of online shopping is that it puts the
Internet's full selection at your fingertips. The downside is that it's harder
to know exactly what you're buying. When it comes to buying medicine, that
downside can be deadly.
Illegal online pharmacies are a particularly dangerous
and elusive sector of the growing problem of counterfeit drugs. The scope of
the Internet compounds the rapid globalization of the drug supply chain and its
increasingly dangerous misuse, making illegal sellers more difficult to trace.
As a result, major Internet players—including Google—are
working with the federal government to battle the problem. Aiming to pinpoint
and verify every alleged online pharmacy is near-impossible, so the focus is
instead on limiting their use through consumer education, restricting their
appearance in Internet searches, and enforcing harsher punishment.
Currently, 35,000 to 50,000 active Internet pharmacies
are believed to be operating, and 97 percent of those surveyed do not meet U.S.
standards, according to a 2013 report from the National Association of Boards
of Pharmacy. This could mean they are not approved by the FDA, or that their
pharmacists are not licensed by the state licensing board.
Counterfeit drugs are often produced in unsanitary
conditions, and they may include none of the active pharmaceutical ingredient,
incorrect dosages, incorrect ingredients, and even poisons. The difference in
composition can cause harm or death in unknowing consumers.
The Food and Drug Administration Safety and Innovation
Act passed in 2012 and the Drug Quality and Security Act of 2013 include
guidance regarding safety of the legitimate drug supply chain. Both laws are in
the process of being implemented, and they involve tighter track and trace
security as drugs travel between manufacturer and patient.
Yet regulating Internet pharmacies can be more
challenging because they sell directly to consumers, and it can be nearly
impossible for patients to know whether a website—and the drug it is selling—is
legitimate.
"There is no one easy bullet or easy solution,"
Bruce Longbottom, assistant general counsel for Eli Lilly, said at a House
Energy and Commerce Committee hearing last week. He suggests patient education,
stronger laws, greater enforcement of existing laws, and coordination with
Internet companies as steps in the right direction.
The global nature of the drug supply chain makes
oversight more difficult, both online and on the ground. About 40 percent of
drugs taken in the U.S. are from overseas, and 80 percent of pharmaceutical
ingredients are made in foreign countries. At the same time, FDA oversight
internationally is even more limited than within the U.S. According to the
Government Accountability Office, the FDA is able to inspect domestic drug
facilities only every two years, and foreign plants just every nine years.
Google, in particular, does not have a clean record in
dealing with international online pharmacies. The company previously allowed
Canadian sellers to advertise through its AdWords program, targeting American
consumers and illegally importing drugs into the U.S. A settlement was reached
in 2011, in which Google forfeited $500 million and agreed to a set of measures
to ensure reporting of counterfeit drug sales to the federal government.
Google is now a member of the Center for Safe Internet
Pharmacies, a nonprofit formed in 2011 with the mission of promoting secure
online pharmacies through "education, enforcement, and information
sharing." This involves both limiting the visibility and accessibility of
rogue sellers, and educating consumers about identifying safe online
pharmacies.
Other CSIP members include Microsoft, Facebook, Yahoo,
Visa, American Express, UPS, and more. The group aims to partner with government
officials, health providers, law enforcement, and other groups to educate
patients about finding safe medicine online; aid law enforcement efforts; and
create a public list of safe websites for consumers.
Internet companies are working to report and remove
illegal pharmacies from Internet search results, while payment networks aim to
prevent payment transactions for illegal drugs.
According to the CSIP website, the coalition participated
in "Operation Pangea" with the FDA in November 2012, shutting down
more than 18,000 illegal pharmacy websites and confiscating $10.5 million worth
of pills. Since 2011, Google has removed more than 3 million advertisements and
made thousands of referrals to law enforcement.
Another piece of addressing the problem is trying to
deter counterfeiters from selling their drugs in the first place, which many
agree requires harsher punishments.
Drug counterfeiting currently has a high financial
incentive and relatively low risk. The industry generated an estimated $75
billion in 2010, according to a study from the Center for Medicine in the
Public Interest. Counterfeiting drugs is considered far more lucrative than
counterfeiting cash.
Yet penalties are limited, and those under FDASIA do not
apply to transactions outside the legitimate drug supply chain. Currently,
selling foreign unapproved drugs is only a misdemeanor, according to Howard
Sklamberg, deputy commissioner for Global Regulatory Operations and Policy at
the FDA. Punishment increases if the government is able to prove fraud, but the
maximum sentence for selling counterfeit drugs is three years in prison, or
$10,000.
Controlling counterfeit drugs is an unusual bipartisan
issue in the current health policy climate.
"I'm pleased we are having an important oversight
hearing where 20 minutes into the hearing no one has blamed the problem on
President Obama," said Rep. Waxman, D-Calif., at the E&C hearing.
"That's rare for this committee."
The cooperation is crucial because the issue of illegal
online pharmacies is so complex and daunting. Even with the collaboration of
the government, Internet providers, pharmaceutical companies, and other
stakeholders, controlling the growing problem of counterfeit drug sales remains
a constant challenge.
"You have an agreement with Google about online
pharmacies?" Republican Rep. Michael Burgess of Texas asked Sklamberg at
the hearing. "Because—I don't want to speak out of school—ut I just typed
'cheap Viagra' into Google, and you get a lot of sites.... I'm not sure that's
working all that well. You might want to check it out."
http://www.nationaljournal.com/health-care/how-google-is-trying-to-protect-your-drug-supply-20140305
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